Schedule 4 (S4) Medical Cosmetic Injectables

Gold Coast Public Health Unit

Schedule 4 (S4)

Medical Cosmetic Injectables

A pilot compliance survey of service

providers

Lisa Mundy

Environmental Health Officer


07 5667 3200

[email protected]

mailto:[email protected]


What are S4 cosmetic injectables?

Cosmetic injectables contain Schedule 4 (S4) medicines or

‘restricted drugs’ and can only be supplied or administered on

written prescription.

Queensland Health currently regulates activity relating to

S4/restricted drugs under the provisions of the

Health (Drugs & Poisons) Regulation 1996.

2 distinct categories of S4 injectables

• Muscle relaxants

• Dermal fillers


Muscle relaxants and fillersS4 Muscle Relaxants S4 Fillers

Botox (onabotulinumtoxin A)

Dysport, (abobotulinum toxin A)

Xeomin (incobotlinum toxin B)

Myobloc (rimabotulinum toxin B)

Restylane, Perlane, Dermalive,

Juvederm, Esthelis, Fortellis,

Princess, Radiess (hyaluronic acid)

Hylaform, Hyalase (hyaluronan,

sodium hyaluronate)

Collagen

Nufill, Sculptra (polylactic acid)

Aquamid (polyacrylamide)

$$$Treatments

are very

expensive!


Why do consumers seek these services?Muscle relaxants - to relax existing

frown lines and prevent formation of

expression lines

(e.g. forehead, eyes, nose, between

eyebrows)

Dermal Fillers - to plump or replace

volume lost with age; to ‘fill’ existing

lines

(e.g. lips, chin, cheeks, nasal folds,

neck)


What can go wrong…

• Reduced viability and effectiveness

• Infections

• Nerve damage

• Paralysis (e.g. part of face such as eyelid)

• Difficulty swallowing and speaking

• Disfigurement (temporary or permanent)

• Death (rare, often confounding factors)


What were we aiming to achieve?

1. Intelligence gathering

Pilot project - Identifying any

emerging public health risks

associated with the industry

practices around S4

cosmetic injectables

• Endorsements for

S4/restricted drugs

• General S4/restricted

drugs provisions

• Counterfeit S4/False

description

• Infection control

provisions

• Poisons/Scheduled

Substances (general)


What were we aiming to achieve?

2. Enforcement Action

for any non-compliance with QH

legislation:

• Health (Drugs and Poisons)

Regulation 1996;

• Health Act 1937 and also

• Chapter 4 of the Public Health Act

2005

• Obtaining

• Possession

• Storage

• Administration

• Disposal


Endorsements for S4s in Queensland

Doctors• Obtain an S4

• Possess an S4 at a place occupied

by the Dr

• Dispense or prescribe the S4 to/for

the person

• Supply or obtain the S4 for the person

• Administer an S4

• OR Give someone who may

administer (endorsed person) an oral

or written instruction to administer

(e.g. an RN under a standing order)– https://www.legislation.qld.gov.au/view/html/inforce/current/sl-1996-0414#sec.161

Registered Nurses• Cannot independently purchase,

administer, store or prescribe S4s

• Can possess S4s at the place of

nursing

• Can administer a dispensed S4

medicine OR under oral or written

instruction of a Dr/authorised

prescriber.

• ‘Cosmetic nursing’ is not recognised

under the Act and Regulation.

• Additional controls on endorsements

for Ens (direct supervision)– https://www.legislation.qld.gov.au/view/html/inforce/current/sl-1996-

0414#sec.175

– https://www.legislation.qld.gov.au/view/html/inforce/current/sl-1996-

0414#sec.162

https://www.legislation.qld.gov.au/view/html/inforce/current/sl-1996-0414#sec.161




Methodology

• Compiled a list of all service providers in Gold Coast jurisdiction

• Web searches/Gumtree/Facebook and covert calling

– (to determine if a Dr is onsite/Dr or RN is administering)

• Developed an audit tool, enforcement guide and guidance note

• Risk assessment of businesses based on type

– (e.g. mobile, home, beauty salon, cosmetician/aesthetician clinics)

• Audits plus relevant seizure and enforcement action

• Referral of issues/trends to QH policy units or other agencies

– (e.g. TGA, AHPRA, OHO, interstate regulatory agencies)

Exclusions

Dentists; Medical practitioners (GP clinic)


Results

18 Service Providers audited late 2014/ early 2015

• All S4 stock was imprest

• No dispensed medicines were being administered

Some good news……

• All legitimate suppliers, TGA approved S4s

• All temp sensitive S4s received under cold chain


Results - obtaining, purchase and storage


Results – storage/reconstitution matters


Results - Administration

• Clients from 11% (2) were not physically assessed

by a Dr

• 22% of assessments by Drs were Tech based

(e.g. skype/videoconference)

• All persons administering were endorsed

– 50% were RNs/50% were doctors

• One RN was administering S4 without the oral/written

instruction of a DR

• Most were under standing orders

– No enrolled nurses were found administering


Main issues identified

• Administration

– Lack of physical/clinical assessment by doctors prior to

prescribing S4s (contrary to Medical Board Code of Conduct)

– RNs administering S4s in the absence of an oral or written

instruction (without a standing order)

• Reconstitution and cold chain (2-8OC)

– Muscle relaxant S4 storage conditions

– Timeframes and cold chain temperature monitoring for

temperature sensitive S4s


Main issues identified (cont.)

• Prescribing, obtaining and purchase orders

– Unauthorised persons obtaining S4s

– Suppliers/wholesalers not checking that the person ordering is

endorsed to obtain S4s (inadequate CAVP)

• Accessibility

– Access to S4s by non-endorsed persons (e.g. beauticians)

• Mobile/independent businesses

– Exponential growth in the industry of mobile businesses or service

providers with Dr/RN working independently

– High use of technology based consults for cosmetic injectables

– Poses a plethora of issues around storage, reconstitution, infection

control


Enforcement actions

• Warning letters or compliance notices issued to all

18 surveyed service providers

• 1 subsequent interview and investigation with an RN

and the prescribing Dr

• No seizures of S4 medicines or other scheduled

drugs and poisons were necessitated


General findings

• No national governance over cosmetic medical services

• Expanding industry with widening demographic

audiences (online, social media, coupon websites)

• ‘Cosmetic’ nursing claimed as a quality benchmark

• PBS medical use of muscle relaxants is expanding

• Advertising of Schedule 4 medicines

• No unlawful sale of S4 medicines uncovered


General Findings

• Infection control

– 7 practices required to have ICMP, only 6 had one.

• Unregulated practices (not covered by ICPAS)

– Contemporary practices have arisen requiring further

attention – e.g. vampire facials (above)

– Various other potential HRPAS were

noted (dermal rolling/skin needling)

• No concerns regarding scheduled poisons

(e.g. S2/S3/S4 topical anaesthesia)

• The cosmetic/beauty industry is extremely complex!!


Project outcomes

Potential policy amendments

• Advocacy for the results to potentially inform new and existing

legislative amendments including:

– consider incorporating minimum standards or a system of

registration for administering RNs to ensure ethical outcomes

– provisions relating to temperature control of drugs and poisons

outside of dispensaries

• Recommend alignment of national and state legislation, practice

standards and frameworks

• Review and streamline referral pathways between agencies


Project Outcomes cont.

Industry/Regulator/Stakeholder communication

• Increased industry awareness of legislative obligations

• Increased enquiries from service providers to GCPHU

• Fact sheet/Communique

- prepared for industry to field the growing number of enquiries from new

and existing cosmetic injectable businesses

- Prepared for future publication as a public health alert in association with

media/social media release


Key project successes

• Audit documents developed to cover the Regulation, Act, Public

Health Act 2005 and other relevant state/national

legislation(TGA/AHPRA)

• Educating EHOs in contemporary application of legislation

• Uncovered key trends/systemic non-compliances in the medical

cosmetic injectable industry

• Developed educational material to inform consumers /industry

• Identified recommended amendments to legislation

• Identified lack of national legislative governance or accreditation for

the cosmetic industry.


Thanks!

Any questions???

Schedule 4 (S4) Medical Cosmetic Injectables

Documents

Transcript of Schedule 4 (S4) Medical Cosmetic Injectables